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QC and analytical support
Quality is guaranteed by advanced resources
and control systems
The Quality Control group has at its disposal a comprehensive
toolbox to control all input and output material within Hovione’s
manufacturing areas. QC Release testing laboratories and a microbiology
laboratory support cGMP production; these labs comply with cGMP standards,
are inspection-ready and operate around the clock.
An additional laboratory is dedicated to support R&D projects, to develop
and validate analytical methods as well as to participate in inter-laboratory
qualification. The level of cGMP depends on the project stage, as defined
in our internal procedure, COP031. A LIMS system is used in the analytical
QC laboratories to guarantee the integrated quality control of raw materials,
intermediates and final products. Material inventory is controlled by a
SAP® ERP that interfaces with our LIMS system.
Quality Control
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Hovione’s quality control is divided
into two separate areas, with QC laboratories dedicated to process
chemistry work and others serving routine production. |
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Our quality control laboratories are comprehensively
equipped with HPLC, GC, NMR, UV, IR, IC, AA, PS, microbiology (bioburden/LAL). |
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In total, 60 people work in quality control. |
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Multi-disciplinary teams ensure smooth project
interaction, as well as technology transfer of analytical methods. |
Comprehensive Analytical Development
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The analytical development laboratory focuses
on providing comprehensive analytical development and validation services. |
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Analytical methods for process control, product
release and intermediate / raw materials release are defined and validated. |
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Identification of impurities, qualification
of reference standards and stability studies conforming to ICH guidelines
are routine services provided. |
Equipment available:
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1 - IR Spectrophotometry
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1 - Atomic Absorption
Spectrophotometry |
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4 - UV-VIS Spectrophotometry
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1 - NIR Spectrophotometry
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30 - HPLC with UV,
diode array, refractive index and electrochemical detectors |
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2 - Ionic chromatography
(with amperometric and conductivity detectors) |
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1 - LC-MS |
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9 - GC with packed
and semi-capillary column and FID detector |
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1 - GC-MS |
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TLC equipment |
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Particle size analysis
equipment (sieving, microscope, Jet Sieve and laser diffraction
(Malvern)) |
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2 - Polarimetry with
Sodium and Mercuric lamp |
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1 - Refractometer
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1 - DCS Equipment
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3 - Karl Fischer |
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1 - Coulometer |
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2 - Melting Point
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5 - pH meters |
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3 - Microscopy |
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2 - Potentiograph |
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1 - Colorimeter |
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2 - Autoclave |
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1 - Temperature Monitoring
System |
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2 - Spectrophotometer
for kinetic turbidimetric endotoxin determination |
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1 - Milliflex unit
filtration for Microbial limits determination |
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1 - Volumetric Sampler
Air |
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About Hovione 
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